MAUDE Adverse Event Report: MITG - OKLAHOMA CITY TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 72203012

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); Radiation Exposure, Unintended (3164)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when the device was being applied to the uterus during a hysteroscopic myomectomy, the inner shaft of the device spun out and wrapped around the outer tube of the device.It was very sharp and jagged metal.This resulted in an extension to the surgical time.It was required to open another device and an x-ray to ensure no material from the device was left behind in the cavity.The procedure was completed with another device and the patient had no postoperative issues.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when the device was being applied to the uterus during a hysteroscopic myomectomy, the inner shaft of the device spun out and wrapped around the outer tube of the device.It was very sharp and jagged metal.This resulted to an extension with the surgical time.Nothing was disengaged from the handpiece.It was required to open another device and an x-ray to ensure no material from the device was left behind in cavity.The procedure was completed with another device and the patient had no post operative issues.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG - OKLAHOMA CITY; 75 s. meridian ave; oklahoma city OK 73107
• Manufacturer (Section G): MITG - OKLAHOMA CITY; 75 s. meridian ave; oklahoma city OK 73107
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 7739253
• MDR Text Key: 115696495
• Report Number: 1643264-2018-02055
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 00885554027617
• UDI-Public: 00885554027617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2020
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Device Lot Number: 4067018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 08/21/2018; 08/08/2018
• Supplement Dates FDA Received: 09/10/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention